FDA approves first over-the-counter birth control pill

WASHINGTON (OSV News) — The Food and Drug Administration announced July 13 it approved the sale of a birth control pill without a prescription for the first time in the United States, a move that will increase the availability of oral contraception and impact ongoing debates about abortion policy post-Dobbs.

In a statement, Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the approval of Opill, a progestin-only pill, “marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States.”

“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” Cavazzoni said.

Currently, a woman seeking to use birth control pills must do so with a doctor’s prescription.

While some have called for expanded access to contraception in the wake of the U.S. Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization, which overturned the high court’s jurisprudence on abortion as a constitutional right, others have argued that proliferating contraception without medical supervision could lead to more unintended pregnancies.

In a guide about the church’s teaching on issues including contraception, the National Catholic Bioethics Center describes contraception as “any action that is specifically intended, whether as an end or as a means, to prevent procreation either before, at the moment of, or after sexual intercourse.”

While contraception “is never to be directly intended,” the guide states, its use for “therapeutic means needed to cure diseases is not illicit, even if it results in a foreseeable impediment to procreation — provided the impediment is not directly intended for any motive whatsoever.”

The Catechism of the Catholic Church teaches that unlike contraception, “the methods of birth regulation based on self-observation and the use of infertile periods, is in conformity with the objective criteria of morality.” These are known as fertility-based awareness methods of family planning; the methods are sometimes collectively referred to as natural family planning.

Opill is expected to be available for retail sale in the U.S. in the first quarter of 2024, its maker, Perrigo, said in a statement.

The FDA said the most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating; and the drug should not be used by those who have or have ever had breast cancer.

Bishop Robert E. Barron of Winona-Rochester, Minnesota, chairman of the U.S. Conference of Catholic Bishops’ Committee on Laity, Marriage, Family Life and Youth, said in a statement that the oral contraceptive announcement “flies in the face of responsible medical practice and concerns for women’s health.”

“Claims that the benefits of this action outweigh the risks are unfounded, especially in light of strong evidence of the many harmful risks of hormonal contraception to women’s health,” the bishop said. “Allowing this hormonal contraception to be dispensed ‘over the counter’ — without the supervision of a doctor and contrary to the mounting evidence of many harmful side effects — violates the Hippocratic Oath by putting the health of women at grave risk.”

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